Summary
This 3-day online training is a deep dive into the world of Biologics. You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the complex regulatory landscape. Topics on regulatory framework (CFR, FDA, EU-GMP guidelines), quality and GMP requirements, manufacturing of the drug substance & IMPs, process validation, managing process changes, analytical methods or the release specification vs IPC requirements will be covered by Dr Felix Kern, the Head of Manufacturing at Merck KGaA, Germany.
Learning Objectives
- Understand the regulatory landscape
- Overview over GMP and quality requirements for the manufacture
- Learn about the development and the requirements for manufacturing
- Modern process validation concepts and biologics
- How to implement effective process changes
- Implementation of analytical methods for biologics and requirements
- Release specification compared to in-process control requirements
Key Topics
- Regulatory framework
- Quality & GMP requirements
- Manufacturing of the drug substance & IMPs
- Process validation
- Managing process changes
- Analytical methods
- Release specification vs IPC requirements
Who should attend?
Quality Assurance and Quality Control Manager, Pharmacovigilance Regulatory Affairs Manager, Process Validation Specialist, Manufacturing Management, Process Development, Research and Development, Certified Management Consultant
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Quality Requirements for Biologics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
